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Completed
NCT03369210
Liberal Transfusion Strategy in Elderly Patients
Conditions: Transfusion-dependent Anemia, Surgery, Anemia
Sex: All
Ages: 70 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 4456
Sponsor: Johann Wolfgang Goethe University Hospital
Location: University Hospital RWTH Aachen
Summary
In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.
Eligibility Criteria
Inclusion Criteria:
* Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered
* Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery
Exclusion Criteria:
* preoperative Hb level ≤ 9 g/dl
* chronic kidney disease requiring dialysis
* suspected lack of compliance with follow-up procedures
* participation in other interventional trials
* expected death within 3 months
* inability to provide informed consent with absence of a legally authorised representative/ legal guardian
* temporary inability to provide informed consent
* previous participation in our trial
* patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses)
* preoperative autologous blood donation.
Source: ClinicalTrials.gov (NCT03369210). StuddyBuddy aggregates publicly available trial information.